Fecal sample testing is useful in detecting, diagnosing and monitoring a variety of diseases. For example, a fecal occult blood (FOB) test allows the detection of an unapparent bleeding beforehand, which may be an early sign of colon-rectal cancer, polyps or inflammatory bowel disease such as Crohn's disease, colitis ulcer, etc. A fecal H. pylori antigen test is able to aid the diagnosis of active infectious of H. pylori and monitor the effectiveness of the treatment. Other fecal pathogen tests such as the detection of specific antigen of rotavirus, adenovirus, Giardia lamblia, Cryptosporidiun parvum and Entamoaba histolytica, etc. are useful in the aid of disease diagnosis and monitor the effectiveness of the treatment. A fecal pancreas elastase-1 test or a fecal chymotrypsin test may aid in the diagnosis of pancreas excretory function. Immunoassays are used for analysis of these specific protein markers.
Recently, immunochromatographic test methods have simplified the immunoassay test procedures and have made such tests less complex. The test can be performed in low-grade clinical laboratories without the high complexity of automated immunoassay systems. This type of assay device is often referred to as a point-of-care test (POCT) device, which is frequently used in the physician's office. Some of the immunochromatographic test devices are also available over the counter (OTC) for consumers to perform the test on site or at home. These tests include urine pregnancy test, ovulation test, some types of drug of abuse tests, etc. Both POCT and OTC test devices are less complex than previous tests such as traditional radioimmunoassay, ELISA, chemiluminescence immunoassay, etc. and are simple and reliable to use.
Although there is POCT for fecal samples such as FOB test device, fecal rotavirus test device, fecal adenovirus test device, fecal H. pylori antigen test device, these test devices are still too complex to be performed with fecal samples by less skilled person without chemistry or laboratory training. The current available fecal sample POCT device is an open test system that includes a fecal sample collection tube with a sample collection strip. After a fecal sample is collected and diluted with a buffer in the collection tube, one is required to transfer a portion of the diluted fecal sample to the fecal POCT strip or cassette device. Therefore, the sample must be exposed to an open test environment. This open test system allows the fecal sample to openly enter the test environment and leak the bad smell. It increases the possibility of potential cross contamination of fecal sample and minimizes the safety and protection for test performer, as well as others working in the same environment. In addition, it is also unpleasant in handling the fecal sample test with this open test system.
Current devices require the transfer of a relatively precise amount of the test sample to an immunochromatographic test cassette/device during the testing procedure. The timing of sample application to the sample pad of the Immunochromatographic test cassette/device is also critical. Therefore, if the test is performed by persons lack of laboratory training in physician's office lab or nursing homes, some problem and mistake may arise during the using of this traditional Immunochromatographic test cassette/device. Moreover, if this type of test cassette/device is use by lay person as an OTC product, because the majority of consumers are not laboratory skilled and are not trained how to perform an immunochromatographic test, unexpected technical problems and mistakes may arise during the using of OTC test device. Therefore there is a need for a fecal test device having a simpler design for less laboratory skilled professionals or laypersons or the home consumer.